Federal Development Update for December 2018

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.

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TSCA/FIFRA/TRI

EPA Publishes First Draft TSCA Chemical Risk Evaluation: On November 15, 2018, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). 83 Fed. Reg. 57473. The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. According to the notice, EPA is also submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) to peer review the draft risk evaluation. EPA published a separate Federal Register notice on November 30, 2018, containing the peer review meeting details. 83 Fed. Reg. 61629. The SACC preparatory virtual pre-meeting will be on January 8, 2019. The four-day in person meeting will be on January 29 to February 1, 2019. Comments on the draft risk evaluation are due January 14, 2019. EPA will provide all comments submitted on the draft risk evaluation to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions. More information is available online.

EPA Withdraws Direct Final SNUR: On November 16, 2018, EPA withdrew 28 significant new use rules (SNUR) previously announced under a direct final rule. 83 Fed. Reg. 57689. EPA received adverse comment from industry and non-governmental organizations (NGO) citing a range of objections to several of the SNURs. EPA was thus required to withdraw the SNURs and must propose them. The direct final rule was issued on September 17, 2018. 83 Fed. Reg. 47004. Also on September 17, 2018, EPA issued proposed SNURs covering the 28 chemical substances. 83 Fed. Reg. 47026. According to the November 16 notice, EPA will address all adverse public comments in a subsequent final rule based on the proposed rule.

U.S. Canada-RCC Stakeholder Forum Includes EPA-PMRA Breakout Session: On November 19, 2018, EPA announced a meeting of the U.S.-Canada Regulatory Cooperation Council (RCC) Stakeholder Forum that took place on December 4, 2018. The RCC brings together senior regulatory officials, industry, and other members of the public from both sides of the U.S.-Canada border to promote economic growth, innovation, competitiveness, and job creation through the elimination of unnecessary regulatory differences between the U.S. and Canada. Canadian and U.S. regulators will provide progress reports on existing regulatory cooperation efforts and solicit public input on new opportunities for regulatory cooperation. During the forum, EPA’s Office of Pesticide Programs (OPP) and Canada’s Pest Management Regulatory Agency (PMRA) lead a breakout session that included updates on the successes of the 2016 work plan and cooperation between the two agencies pertaining to pesticide registration. The U.S. and Canadian agencies are working together to:

Collaborate on a bilateral pesticide re-evaluation for three neonicotinoid pesticides (i.e., imidacloprid, thiamethoxam, and clothianidin) employing a new pollinator risk assessment framework;

Develop best practices for coordinated work planning for the re-evaluation of registered pesticides;

Develop new and/or alternative approaches to testing and assessment, including reducing the need for animal testing wherever possible;

Align pesticide residue trial requirements by prospectively determining the number of residue field trials required for joint registrations; and

Jointly develop information technology solutions that facilitate the submission of applications to either regulatory authority.

EPA Announces Human Health Toxicity Assessments For GenX Chemicals, PFBS, And Related Compound Potassium Perfluorobutane Sulfonate: On November 21, 2018, EPA announced a 60-day public comment period associated with the release of two draft toxicity assessments for public comment. 83. Fed. Reg. 58768. The two assessments are:

EPA developed the draft assessments to provide the health effects information available for GenX Chemicals and PFBS and describe in the assessments how that information was used to derive draft toxicity values. Following closure of the public comment period, EPA will consider the comments, revise the draft documents, and consider the need for additional peer review, as appropriate, and then publish final toxicity assessments. The toxicity assessments for GenX Chemicals and PFBS are scientific and technical reports that include toxicity values associated with potential noncancer health effects following oral exposure (in this case, oral reference doses RfD)). The toxicity assessments and the values contained within are not risk assessments as they do not include exposure assessments or provide a risk characterization. Comments are due by January 22, 2019.

EPA Announces New Acting Deputy AA At OCSPP: On November 26, 2018, EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) announced that Lek Kadeli joined OCSPP’s Immediate Office as Acting Deputy Assistant Administrator (AA) (Management). EPA states that Kadeli has extensive experience managing and supporting a wide range of environmental and human health related programs. Kadeli has worked at EPA previously; for eight years he was the Principal Deputy AA in EPA’s Office of Research of Development (ORD), serving several periods during that time as ORD’s Acting AA. Kadeli has also served as Director for ORD’s Office of Resource Management and Administration; Chief of ORD’s Resources Planning and Execution Staff; Office of International Activities Senior Budget Officer; and as a budget analyst in the Office of Administration and Resource Management’s Office of Comptroller.

Most recently, Kadeli worked at the World Bank Group in Washington, D.C. as the co-program manager of the Pollution Management and Environmental Health Program, Environment and National Resources Global Practice. Kadeli holds a B.A. in Political Science from George Mason University, and a M.A. in National Security Studies from Georgetown University.

EPA Seeks Comment On Several TSCA ICRs: On November 27, 2018, EPA requested comment on several information collection requests (ICR) involving three different TSCA reporting obligations. The first addresses an ICR submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): ‘‘PCBs, Consolidated Reporting and Record Keeping Requirements,’’ identified by EPA ICR Number 1446.12 and OMB Control Number 2070–0112. 83 Fed. Reg. 60844. The ICR provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in the notice. The action is a request to renew the approval of an existing ICR. The second involves “Premanufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances” (EPA ICR No. 0574.18, OMB Control No. 2070–0012). 83 Fed. Reg. 60845. The third involves “Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies,” identified by EPA ICR No. 0575.16 and OMB Control No. 2070-0004. 83 Fed. Reg. 60853. Comments on each are due by December 27, 2018.

EPA Issues Proposed Rule To Harmonize EPA-Specific Regulations In Revised Common Rule:On December 6, 2018, EPA announced it was proposing a rule to harmonize the EPA-specific regulations regarding research involving human subjects conducted or sponsored by EPA or submitted to EPA for regulatory purposes with the revised regulations of the Federal Policy for the Protection of Human Subjects (Common Rule) issued on January 19, 2017 (82 Fed. Reg. 7149). 83 Fed. Reg. 62760. Specifically, EPA is proposing to amend Subparts C, D, K, and M of its regulations relating to human research. Subpart K, titled “Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults,” contains the majority of the revisions. Subparts C and D will be revised to update several numerical citations and Subpart M will be revised to correct a typographical error. Comments on the proposed rule are due by February 4, 2019. More information is available in our blog.

EPA Seeks Comment On SACC Nominees: On December 14, 2018, EPA published a Federal Register notice requesting public review and comments on the scientific experts nominated to be considered for ad hoc participation and possible membership on the TSCA SACC. 83 Fed. Reg. 64341. Nominations that were received in response to a prior notice are being considered for ad hoc participation on an as needed basis for the TSCA SACC’s peer reviews of EPA’s risk evaluations for chemical substances addressed under TSCA. In addition, all nominees are under consideration for TSCA SACC membership to fulfill short-term needs when a vacancy occurs on the chartered Committee. Brief biographical sketches of nominees to be considered for ad hoc participation and possible membership on the TSCA SACC are posted on the TSCA SACC website at http://www.epa.gov/?tsca-peer-review or may be obtained from the Office of Pollution Prevention and Toxics (OPPT) Docket (EPA-HQ-OPPT-2018-0605) at http://www.regulations.gov. Comments are due on January 14, 2019.

RCRA/CERCLA/CWA/CAA/SDWA/PHMSA

EPA Revises Superfund Target List And Amends Criteria For Adding Sites:On November 20, 2018,EPA released a third revision to the Administrator’s Emphasis List of Superfund Sites Targeted for Immediate, Intense Action. EPA removed the West Lake Landfill site in Bridgeton, MO, from the list and added the Universal Oil Products, East Rutherford, NJ; Allied Paper, Kalamazoo, MI; and Madison County Anschutz Mine, Fredericktown, MO, sites to the list. With this update, there are 16 Superfund sites on the list. EPA also revised the criteria for adding sites to the list. EPA will now consider adding sites based on one or more of the following criteria:

Sites where the Administrator’s attention may help to enhance human health and environmental protection, promote more timely resolution of issues, advance more effective cleanup, or promote redevelopment opportunities;

Sites in diverse geographical areas and in various environmental settings;

Sites that are addressing different contaminants;

Both Fund and potentially responsible party lead sites; and

Sites that are representative of other sites, which can provide lessons learned and best practices for similar sites.

DOT Issues Immediately Effective Rule Setting Minimum And Maximum Civil Penalties: On November 27, 2018, the Department of Transportation (DOT) issued an immediately effective final rule adjusting minimum and maximum civil penalties for the agencies under its authority. 83 Fed. Reg. 60732. The rule applies to the Federal Aviation Administration (FAA), the Pipeline and Hazardous Materials Administration (PHMSA), the Federal Railroad Administration (FRA), and other agencies. The rule implements the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). The FCPIAA and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act) require federal agencies to adjust minimum and maximum civil penalty amounts for inflation to preserve their deterrent impact. The 2015 Act amended the formula and frequency of inflation adjustments. It required an initial catch-up adjustment in the form of an interim final rule, followed by annual adjustments of civil penalty amounts using a statutorily mandated formula. Section 4(b)(2) of the 2015 Act specifically directs that the annual adjustment be accomplished through final rule without notice and comment. The rule generally raises penalties by slightly over one percent.

PHMSA Proposes Revisions To HMRs To Align With International Standards: On November 27, 2018, in a Notice of Proposed Rulemaking (NPRM), PHMSA proposed dozens of revisions to the hazardous materials regulations (HMR) aligning them with international HMRs. 83 Fed. Reg. 60970. PHMSA is proposing changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. PHMSA states that these revisions are necessary to harmonize the HMR with recent changes made to the International Maritime Dangerous Goods Code (IMDG Code), the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), and the United Nations Recommendations on the Transport of Dangerous Goods -- Model Regulations (UN Model Regulations). Additionally, PHMSA proposes several amendments to the HMR that would allow for increased alignment with Transport Canada, Transportation of Dangerous Goods (Transport Canada TDG). Among other changes, PHMSA is proposing the following revisions to the HMRs:

Incorporation by Reference: PHMSA proposes to incorporate by reference the newest versions of various international hazardous materials standards, including: the 2019–2020 Edition of the ICAO Technical Instructions; Amendment 39-18 to the IMDG Code; the 20th Revised Edition of the UN Model Regulations; Amendment 1 to the 6th Revised Edition of the UN Manual of Tests and Criteria; and the 7th Revised Edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Additionally, PHMSA proposes to update its incorporation by reference of the Transport Canada TDG Regulations to include: SOR/2016-95 published June 1, 2016; SOR/2017-137 published July 12, 2017; and SOR/2017-253 published December 13, 2017. Finally, in this NPRM, PHMSA proposes the adoption of updated International Organization for Standardization (ISO) standards.

Articles Containing Dangerous Goods: PHMSA proposes to add a classification system for articles containing hazardous materials that do not already have a proper shipping name. This proposal would address situations in which hazardous materials or hazardous materials residues are present in articles, and authorize a safe method to transport articles that may be too large to fit into typical packages.

Lithium Battery Test Summary: PHMSA proposes the inclusion of a lithium battery test summary requirement. The HMRs require lithium battery manufacturers to subject their batteries to appropriate UN design tests to ensure they are classified correctly for transport, and develop records of successful test completion. The proposed test summary would include a standardized set of elements that provide traceability and accountability, thereby ensuring that lithium cell and battery designs offered for transport meet the appropriate UN tests.

Baggage Equipped with Lithium Batteries: PHMSA proposes to amend the aircraft passenger provisions for carriage of baggage equipped with lithium batteries intended to power features such as location tracking, battery charging, digital weighing, or motors (sometimes referred to as “smart luggage”). Specifically, baggage equipped with a lithium battery or batteries would be required to be carried in the cabin of the aircraft unless the battery or batteries are removed.

Segregation of Lithium Batteries from Specific Hazardous Materials: PHMSA proposes requirements to segregate lithium cells and batteries from certain other hazardous materials, notably flammable liquids, when offered for transport or transported on aircraft. PHMSA is taking this action to promote consistency with the ICAO Technical Instructions and a recommendation (A16-001) from the National Transportation Safety Board (NTSB) stemming from the investigation of the July 28, 2011, in-flight fire and crash of Asiana Airlines Flight 991 incident that resulted in the loss of the aircraft and crew. The investigation report cited as a contributing factor the flammable materials and lithium ion batteries that were loaded together either in the same or adjacent pallets.

Alternative Criteria for Classification of Corrosive Materials: PHMSA proposes to include non-testing alternatives for classifying corrosive mixtures that use existing data on their chemical properties. Currently the HMRs require offerors to classify Class 8 corrosive material and assign a packing group based on test data. The HMRs authorize a skin corrosion test and various in vitro test methods that do not involve animal testing. Data obtained from testing, however, is currently the only data acceptable for classification and assigning a packing group. These alternatives would afford offerors the ability to make a classification and packing group assignment without the need to conduct physical tests.

Provisions for Polymerizing Substances: PHMSA is proposing to extend the sunset dates for provisions concerning the transportation of polymerizing substances from January 2, 2019, to January 2, 2021. This additional time will allow PHMSA to finalize research and analyze comments and data concerning the issue submitted to the docket for this NPRM. This information will allow PHMSA to have a more comprehensive understanding of polymerizing substances and further consider the most appropriate transport provisions for these materials.

Comments are due by January 28, 2019.

EPA Deletes Compound From List Of VOCs Regulated Under The Clean Air Act: On November 28, 2018, EPA issued a final rule revising the regulatory definition of volatile organic compounds (VOC) under the Clean Air Act (CAA). 83 Fed. Reg. 61127. EPA deleted cis-1,1,1,4,4,4-hexafluorobut-2-ene (HFO-1336mzz-Z; Chemical Abstracts Service (CAS) Number 692-49-9) from the regulatory list of VOCs after determining that it makes a negligible contribution to tropospheric ozone formation. The products and industries most affected by this revision include polystyrene foam, urethane foam, air conditioning heating equipment, commercial industrial refrigeration equipment manufacturing, motor vehicle parts manufacturing, ship building and repair, and boat building. EPA deleted the compound in response to a 2014 petition from DuPont Chemicals & Fluoroproducts (DuPont). DuPont’s petition sufficiently demonstrated the negligible ozone formation potential of the compound. In addition to CAA regulations, this final rule will impact the regulation of this compound across other regulatory programs, including TSCA and the Emergency Planning and Community Right-to-Know Act (EPCRA). The rule will be effective on January 28, 2019.

EPA Publishes RCRA Airbag Exemption Rule: EPA on November 30, 2018, published its final rule in the Federal Register promulgating a conditional exemption for recalled airbag inflators. 83 Fed. Reg. 61552. The rule was effective on November 30, 2018, but EPA is accepting comment on it until January 29, 2019. We summarized the rule in our November 2018 regulatory update, which is available online.

EPA Announces RMP Revisions Are In Effect: On December 3, 2018, EPA issued a final rule stating that the amendments to the Risk Management Program (RMP) under the CAA that EPA promulgated on January 13, 2017 (82 Fed. Reg. 4594) are in effect as of December 3, 2018. 83 Fed. Reg. 62268. EPA delayed the rule’s effective date three times: on January 26, 2017 (82 Fed. Reg. 8499), March 16, 2017 (82 Fed. Reg. 13969), and June 14, 2017 (82 Fed. Reg. 27133). On August 17, 2018, the U.S. Court of Appeals for the District of Columbia Circuit vacated the June 14, 2017, rule that had delayed the effective date of the RMP amendments rule until February 19, 2019. On September 21, 2018, the Court issued its mandate which makes the RMP amendments now effective. The amendments are intended to modernize EPA’s RMP regulations as required under Executive Order (EO) 13650, which directs the federal government to carry out certain tasks intended to prevent chemical incidents, such as the explosion in West, Texas, on April 17, 2013. Specifically, the amendments are intended to address and improve accident prevention program elements; enhance the emergency preparedness requirements; and ensure Local Emergency Planning Committees, local emergency response officials, and the public can access information in a user-friendly format to help them understand the risks at RMP facilities and better prepare for emergencies.

EPA Proposes To Revise NSPS For Fossil Fuel-Fired Power Plants:EPA announced its proposal to revise the New Source Performance Standards (NSPS) under the CAA for greenhouse gas emissions from new, modified, and reconstructed fossil fuel-fired power plants. EPA is proposing under CAA Section 111(b) to revise its determination of the best system of emission reduction (BSER) for these plants. This determination would replace EPA’s 2015 determination that partial carbon capture and storage (CCS) technology was the BSER for new coal units. Specifically, EPA proposes to determine that the BSER for newly constructed coal-fired units is the most efficient demonstrated steam cycle in combination with best operating practices. EPA blamed high costs and limited geographic availability of CCS for requiring revisions to the NSPS. The proposal includes four actions based on a revised BSER:

Revising the standards for newly constructed steam units as separate standards for large and small units. For large units, the proposed emission rate would be 1,900 pounds of carbon dioxide (CO2) per megawatt-hour on a gross output basis (lb CO2/MWh-gross). For small units, the proposed emission rate would be 2,000 lb CO2/MWh-gross.

Amending the standards for large modifications of steam generating units to be consistent with the standards for large and small newly constructed units.

Changing the standards of performance for reconstructed fossil fuel-fired steam units to be consistent with the emission rates for newly constructed units.

In addition to these proposed revisions, EPA seeks comment on whether and how to address concerns raised by stakeholders regarding the increased use of simple cycle aeroderivative turbines. EPA is also taking comment on the regulatory threshold under Section 111(b) that a source category “causes, or contributes significantly to,” air pollution. EPA asks for the public’s views on the proper interpretation of this phrase, EPA’s past approach to this requirement, and whether this requirement should apply differently in the context of greenhouse gases than for traditional pollutants. Comments will be due after the rule is published in the Federal Register.

EPA Releases WOTUS Replacement Rule Proposal: On December 11, 2018, EPA’s Acting Administrator Andrew Wheeler announced EPA’s and the U.S. Army Corps of Engineers’ (Corps) release of their highly anticipated proposed replacement definition of “Waters of the U.S.” (WOTUS) that defines the scope of waters and wetlands that fall under federal Clean Water Act (CWA) jurisdiction. The 2018 WOTUS rule proposal is currently available in pre-publication format on EPA’s website here along with several fact sheets and other supporting materials. At this time, it is unclear as to what date EPA and the Corps will publish the proposal in the Federal Register and officially begin to accept public comment. More information is available in our memorandum.

EPA Proposes Revisions To Stormwater NPDES Permits For Construction Activities: EPA on December 12, 2018, proposed revisions to the National Pollutant Discharge Elimination System (NPDES) general permit for stormwater discharges associated with construction activities. 83 Fed. Reg. 63858. EPA proposes to remove from the definition of “operator” the examples of the type of party that may be considered an operator. The revisions clarify that if a party wishes to obtain coverage under the 2017 Construction General Permit (CGP) for its stormwater discharges from construction activities, it is the operator who is responsible for submitting to EPA a Notice of Intent (NOI) for coverage under the permit. EPA also proposes to revise two erosion and sediment control requirements and one pollution prevention requirement in the 2017 CGP to clarify their intent. EPA further proposes to modify the 2017 CGP to clarify an individual operator’s legal responsibility for permit compliance in situations where there are multiple operators who divide permit responsibilities. Specifically, EPA proposes to remove references to joint and several liability from the current permit since they are, in EPA’s view, an inaccurate explanation of what the permit compliance duties are for multiple operators who share implementation responsibilities under the permit. Comments must be received by January 28, 2019.

EPA Streamlines Hazardous Waste Regulations For Pharmaceuticals: EPA Acting Administrator Andrew Wheeler on December 11, 2018, signed a final Resource Conservation and Recovery Act (RCRA) rule streamlining standards for managing hazardous waste pharmaceuticals. The final rule will be published shortly in the Federal Register. Certain pharmaceuticals are regulated as hazardous waste under RCRA when discarded. This final rule removes these pharmaceuticals from full RCRA regulation and creates a new Part 266 Subpart P for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. Healthcare facilities (for both humans and animals) and reverse distributors will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards in lieu of RCRA generator regulations in Part 262. The new rule also prohibits the disposal of hazardous waste pharmaceuticals down the drain -- “sewering” -- and eliminates the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances. The rule maintains the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take-back programs and events. The new Subpart also codifies EPA’s prior policy on the regulatory status of nonprescription pharmaceuticals going through reverse logistics. Specifically, the rule reaffirms that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being used/reused or legitimately reclaimed are not solid or hazardous waste. EPA also is amending the P075 acute hazardous waste listing of nicotine and salts to exclude certain U.S. Food and Drug Administration (FDA) approved over-the-counter (OTC) nicotine replacement therapies (NRT). The final rule also establishes a policy on the regulatory status of unsold retail items that are not pharmaceuticals and are managed via reverse logistics. The revisions promulgated by EPA will only be effective in those states that do not have final authorization of their base RCRA programs, i.e., Alaska and Iowa. EPA is, however, promulgating the prohibition of “sewering” hazardous waste pharmaceuticals under the authority of the Hazardous and Solid Waste Amendments (HSWA) in Section 3018 of RCRA. That prohibition thus will become effective in all states upon the effective date of the rule. The revisions will become effective in those states with RCRA authorized programs only when the states adopt the revisions, although they are not required to do so. The rule will become effective six months after it is published in the Federal Register. A pre-publication copy of the rule is available here.

FDA

FDA Advances Development Of New Consumer Survey Assessing Allergens In Cosmetics: On November 8, 2018, FDA announced an opportunity for public comment on a pilot study entitled “Web-based Pilot Survey to Assess Allergy to Cosmetics in the United States.” 83 Fed. Reg. 55896. The web-based consumer survey will focus on allergens in cosmetics, including fragrances, hair products, makeup, nail products, and skin care products. The people invited to participate in the survey will be selected to be representative of U.S. adults. FDA states that the survey will “help the agency better understand consumer perceptions and awareness regarding allergens in cosmetics as well as consumer decisions about whether to purchase specific products or to avoid certain ingredients, when to contact a health care professional, and when to report an adverse event.” To conduct the survey, FDA must receive approval from OMB; if OMB approval is received, FDA states it expects to begin conducting the new consumer survey in 2019. Comments are due by January 7, 2019.

Listeria monocytogenes illnesses were most often linked to dairy products and fruits; and

Campylobacter illnesses were most often linked to chicken after removing dairy outbreaks from the estimates.

FDA Reminds Constituents To Obtain Third-Party Certifications; Updates Guidance For Industry On Exports Of Milk, Seafood, Infant Formula, And Formula For Young Children To China: On November 27, 2018, FDA updated its Constituent Update regarding its Memorandum of Understanding (MOU) with China to outline a certification process for certain exports, specifically to remind U.S. establishments that are currently listed on the dairy, seafood, and infant formula exports lists for China that the Certification and Accreditation Administration of the People’s Republic of China (CNCA) requires them to obtain third-party certification of compliance with the relevant standards, laws, and regulations of China by June 15, 2019, if they wish to maintain continued access to the Chinese market. To remain on the lists, establishments will need to submit evidence of their third-party certifications via the Export Listing Module (ELM) before the June 15, 2019, deadline. FDA also updated its related guidance for industry titled “Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China” to further explain how establishments should apply to be included on FDA’s lists of exporters to China using the new ELM, how FDA intends to determine whether the establishment should be recommended for inclusion for specific products, and how FDA intends to update this information.

FDA Adds Resources To Assist Food Facilities With Biennial Registration Renewal: On November 28, 2018, FDA issued a Constituent Update stating that it is adding resources to assist food facilities with their biennial registration renewals.Food facilities that are required to register with the FDA must renew their registration this year between October 1, 2018, and December 31, 2018. Two new resources FDA released to assist food facilities in this process are:

A fact sheet to explain what food facilities need to know about this year’s biennial registration renewal period. The fact sheet answers questions such as: Who needs to register? How can food facilities go about renewing their registration? And how can facilities save time during the renewal process?

FDA To Allow Stakeholders To Comment On First And Second Installments Of Intentional Adulteration Draft Guidance Together: On December 4, 2018, FDA issued a Constituent Update stating that stakeholders will be able to comment on the first two installments of the draft guidance for industry titled Mitigation Strategies to Protect Food Against Intentional Adulteration together. FDA states that even though the closing date for public comment on the first installment of the draft guidance is December 17, 2018, it intends to ask for comments on both the first and upcoming second installments during the comment period after the second installment is issued. The first installment, released in June 2018, was designed to support compliance with the Intentional Adulteration final rule (IA rule) under the Food Safety Modernization Act (FSMA). The second installment of the draft guidance will be presented in early 2019 alongside the first installment, and the public can view content from both together. FDA states it wants to give stakeholders an opportunity to consider the available guidance materials when drafting their comments. When the second installment is published, there will be an additional 120 days to comment on the expanded guidance. The first compliance date for larger businesses under the IA Rule is July 26, 2019.

FDA Issues RFI To Assess The Safety And Effectiveness Of OTC Antiseptic Drug Products: On December 7, 2018, FDA announced that it issued a Request for Information (RFI) and established a docket to obtain data, information, and comments that will assist in assessing the safety and effectiveness of OTC food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings). 83 Fed. Reg. 63168. FDA states that it has “tentatively concluded that, based on FDA’s current categorization of other antiseptic products and considering factors that may include specific microorganisms of concern in food handling environments as well as the safety of repeated-exposure use patterns, food handler antiseptics may differ from antiseptic products addressed in other rulemakings.” Through this RFI, FDA is asking manufacturers of food handler antiseptics and other interested parties to submit safety and effectiveness data on OTC food handler antiseptics marketed for in commercial or regulated environments where growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service or consumption of food occurs. FDA is also seeking comments and requesting data on definitions, eligibility, current conditions of use of food handler antiseptics, safety and effectiveness criteria, and test methods to demonstrate the safety and effectiveness of food handler antiseptics. Comments are due by February 5, 2019.

NANOTECHNOLOGY

SweNanoSafe Reports On ECHA Workshop On REACH Requirements For Nanomaterials: The Swedish National Platform for Nanosafety (SweNanoSafe) has posted a report on the European Chemicals Agency’s (ECHA) November 8-9, 2018, workshop on the upcoming Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) information requirements for nanomaterials. The workshop was a preparatory step before the formal start of the update of ECHA’s guidance documents for nanomaterials through the Partner Expert Group. The timeframe for the work will be short as the finally agreed proposals should be adopted by the European Commission (EC) around November 2019. Thereafter, ECHA will publish the updated nanomaterial guidance on their homepage for immediate use.

EC Amends REACH To Require Information On Nanomaterials: The EC announced on December 3, 2018, that it adopted amendments to several REACH Annexes to clarify the information requirements for nanomaterials. The EC states that “[t]he new provisions will have to be implemented for all substances in nanoform that fall within the scope of REACH, from the already widely used and registered ‘legacy’ nanomaterials in all their product grades and variations to the specifically engineered nanomaterials placed on the market by the newly founded SMEs.” ECHA’s December 3, 2018, press release states that nanoforms of substances are those covered by the EC’s recommendation for a definition of a nanomaterial. The information requirements will apply beginning January 1, 2020.

EPA Withdraws SNUR For Carbon Nanomaterial (Generic): EPA published a Federal Register notice on December 4, 2018, withdrawing SNURs promulgated under TSCA for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 62463. As reported in our October 2, 2018, blog item, EPA issued the SNURs through a direct final rule on October 3, 2018. EPA states that it received adverse comments regarding the SNURs identified in the direct final rule, and is withdrawing them. On October 3, 2018, EPA also issued proposed SNURs covering these 26 chemical substances. EPA states that it will address all adverse public comments in a subsequent final rule, based on the proposed SNURs.

EPA Withdraws SNUR For Single-Walled Carbon Nanotubes: EPA published a Federal Register notice on December 7, 2018, withdrawing SNURs promulgated under TSCA for 28 chemical substances, including single-walled carbon nanotubes, that were the subject of PMNs. 83 Fed. Reg. 63066. As reported in our October 10, 2018, blog item, EPA issued the SNURs through a direct final rule on October 10, 2018. EPA states that it received adverse comments regarding the SNURs identified in the direct final rule, and is withdrawing them. On October 10, 2018, EPA also issued proposed SNURs covering these 28 chemical substances. EPA states that it will address all adverse public comments in a subsequent final rule, based on the proposed SNURs.

Canada’s Occupational Cancer Research Center Holds Seminar On Mitigating Exposures To Engineered Nanomaterials In The Workplace: On December 7, 2018, the Occupational Cancer Research Center (OCRC) held a seminar on “Perspectives on Mitigating Exposures to Engineered Nanomaterials in the Workplace.” The seminar was part of the Occupational and Environmental Health seminar series supported by the Dalla Lana School of Public Health, Public Health Ontario, OCRC, and the Center for Research Expertise in Occupational Disease. Pat Rasmussen, Health Canada/University of Ottawa, gave the presentation, addressing several topics: the unique properties of engineered nanomaterials (definitions); control banding approach: Selection of control measures based on hazard and exposure (Canadian Standards Association (CSA)/ISO); harmonized tiered approach: To assess potential exposures in workplaces (Organization for Economic Cooperation and Development (OECD)); how research feeds into CSA/ISO and OECD exposure measurement and mitigation efforts; and accessing nano workplace safety information in Ontario.

Great Lakes Water Protection Act Introduced In Senate: Senator Tammy Duckworth (D-IL) on November 15, 2018, introduced the Great Lakes Water Protection Act (S. 3630). The bill would amend the CWA to prohibit a publicly owned treatment works (POTW) from performing a bypass into the Great Lakes System. The bill defines “bypass” to mean “an intentional diversion of waste streams from any portion of the treatment facility.” Bypasses would be allowed if: necessary to prevent loss of life, personal injury, or severe property damage; if there is no feasible alternative to the bypass; the owner or operator of the POTW provides notice of the bypass; or the bypass will not cause effluent limitations to be exceeded and is for essential maintenance to ensure efficient operation of the treatment facility. This latter exemption would not apply, however, if adequate back-up equipment should have been installed in the exercise of reasonable engineering judgment to prevent the bypass and the bypass occurred during normal periods of equipment downtime or preventive maintenance. The legislation also would create the Great Lakes Cleanup Fund. The fund would be used to carry out programs and activities for improving wastewater discharges into the Great Lakes System, including habitat protection and wetland restoration programs and activities. The fund would be set at $250 million a year for fiscal years (FY) 2020 through 2024.

House Bill Would Require EPA To Review NESHAP For Ethylene Oxide: Representative Daniel Lipinksi (D-IL) on November 20, 2018, introduced legislation to address air emissions of ethylene oxide. The Clean Up EtO Act of 2018 (H.R. 7168) would require EPA to review, and if necessary, revise the National Emission Standard for Hazardous Air Pollutants (NESHAP) applicable to emissions of ethylene oxide from regulated facilities. EPA would have nine months to do so. In addition, if EPA deems it necessary to revise the standards, the bill would require it to control emission of ethylene oxide from chamber exhaust vents.

Bipartisan Carbon Tax Bill Introduced In House: On November 27, 2018, bipartisan lawmakers introduced a bill in the House of Representatives that would create a Carbon Dividend Trust Fund to encourage “market-driven innovation of clean energy technologies and market efficiencies which will reduce harmful pollution and leave a healthier, more stable, and more prosperous nation for future generations.” The Energy Innovation and Carbon Dividend Act of 2018 (H.R. 7173) was sponsored by Representatives Ted Deutch (D-FL), Francis Rooney (R-FL), Charlie Crist (D-FL), Brian Fitzpatrick (R-PA), and John Delaney (D-MD). It is the first carbon tax bill introduced in Congress in a decade. The bill would impose a tax of $15 per metric ton on carbon emissions, beginning in 2019. The tax would increase by $10 per metric ton every year thereafter. The tax would apply to greenhouse gas emitting fuels used by entities subject to the legislation. It also would apply to the sale or transfer of the fuels. Agricultural fuels used for “non-emitting purposes” would be exempt from the tax. The bill seeks to reduce carbon emissions in the U.S. by 33 percent over ten years and 90 percent by 2050. The bill also would impose a tariff on imports that are not subject to a similar tax in their country of origin.

Senate And House Bills Would Require EPA To Revise Air Standards For Ethylene Oxide: On November 28, 2018, Senators Dick Durbin (D-IL) and Tammy Duckworth (D-IL) introduced a bill that would require EPA to revise ethylene oxide emissions standards under the CAA for medical sterilization and chemical facilities. The bill (S. 3671) also requires EPA to notify the public no more than 30 days after it learns that the new standards have been violated. Companion legislation (H.R. 7179) was similarly introduced in the House by Democratic Representatives Dan Lipinski, Brad Schneider, and Bill Foster.

Senate Bill Seeks To Transition U.S. To 100 Percent Zero-Emission Vehicles: On November 28, 2018, Senators Jeff Merkley (D-OR) and Sheldon Whitehouse (D-RI), both senior members of the Senate Environment and Public Works (EPW) Committee, introduced legislation that would put the U.S. on the path to achieving 100 percent zero-emission vehicles (ZEV). The Zero-Emission Vehicles Act (S. 3664) builds on actions taken by ten states that have enacted state-level ZEV standards. The bill would set a comprehensive federal ZEV standard. By 2030 at least 50 percent of all new car sales in the U.S. must be ZEVs. The legislation then ramps up the percentage by five percent each year, with automobiles being ZEVs by 2040. The federal ZEV standard would include a crediting system. Each ZEV would receive one ZEV credit per vehicle. Plug-in hybrids and hybrids receive partial credits based on the estimated average portion of mileage traveled on the battery instead of fossil fuels. Fuel efficient vehicles can receive partial credits based on EPA’s estimated fuel savings. ZEV credits would be allocated to automobile manufacturers, and can be sold or banked for up to five years, until 2040. Revenues from the sales of ZEV credits will help support public infrastructure through the Highway Trust Fund.

Senate EPW Committee Holds Hearing On Nomination Of Alexandra Dunn To Lead OCSPP:On November 29, 2018, the U.S. Senate Committee on EPW held a hearing on the nomination of Alexandra Dapolito Dunn to be the AA for EPA’s OCSPP. The hearing was webcast and is available on the EPW Committee website. In a rare sharing of bipartisan support for a Trump Administration nominee, Senator Sheldon Whitehouse (D-RI) introduced Ms. Dunn, stating “Ms. Dunn has a deep passion for working with communities, for environmental justice, and for leveraging the expertise of nongovernmental organizations.” Senator Tom Carper (D-DE) stated he was encouraged by her plans for the office. Ms. Dunn assured lawmakers that, if confirmed, she will “commit to implementing the law, following the law, and bringing all the provisions of the law to full effect.” Ms. Dunn also emphasized her intention, if confirmed, to leverage the experience and expertise of EPA career staff, including establishing “open door” hours dedicated to connecting with career staff. Ms. Dunn’s written testimony is available on the EPW Committee website. Senators were allowed to submit additional questions for the record (QFR) through November 29, 2018, for Ms. Dunn’s response by December 3, 2018. It is being reported that Ms. Dunn could be confirmed this year assuming there are no objections. Ms. Dunn has been serving as the Regional Administrator for EPA’s New England Region (Region 1) since January of this year. Prior to joining EPA, Ms. Dunn served as Executive Director and General Counsel for the Environmental Council of the States (ECOS), a national nonprofit, nonpartisan organization committed to helping state agencies improve environment outcomes for Americans. More information on Ms. Dunn’s experience and accolades is available in EPA’s press release announcing her nomination.

Illinois Lawmakers Introduce Bills To Update National Air Toxics Assessment For Ethylene Oxide: On November 29, 2018, Illinois Democratic Senators Dick Durbin and Tammy Duckworth, along with their House colleagues Bill Foster, Daniel Lipinski, and Brad Schneider, introduced the Expanding Transparency of Information and Safeguarding Toxics (EtO is Toxic) Act of 2018 (S. 3691 and H.R. 7189). The legislation would require EPA to publish its Integrated Risk Information System (IRIS) and its National Air Toxic Assessment (NATA) assessments in the Federal Registry where it would be accessible to state and local health agencies, other federal agencies, and international health organizations.

House Bill Would Extend CFATS For Two Years: On November 29, 2018, Representative John Ratcliffe (R-TX) introduced legislation that would extend by two years the Chemical Facility Anti-Terrorism Standards (CFATS) program. The four-year authorization of the CFATS is set to expire in January 2019.

Bill Would Repeal WOTUS Rule: On November 29, 2018, Representative Jaime Herrera Beutler (R-WA) introduced a bill to repeal the controversial WOTUS rule and clarify that the CWA remains in effect as it has been interpreted for more than four decades. Representative Herrera Beutler stated that the current WOTUS rule expands the definition of “navigable waters” under the CWA to include water that is not “navigable” under any previous interpretation or common sense definition, including seasonal wet spots, puddles, and small man-made ditches. “WOTUS would require private landowners with such puddles and ditches on their property to obtain costly CWA permits when improving their land, costing thousands of dollars and years of wait time,” she explained. The bill (H.R. 7194) would clarify that “navigable waters” includes territorial seas, interstate waters that are navigable-in-fact, tributaries to the interstate, navigable-in-fact waters, and wetlands that have a continuous surface water connection to interstate, navigable-in-fact waters or their tributaries. The legislation also blocks the federal government’s ability to grant itself the authority to regulate seasonal wet areas, ponds, puddles, and ditches as “navigable waters,” whether on public or private property. The bill, titled Regulatory Certainty for Navigable Waters Act, would also require the Corps to act upon request within 60 days to determine whether water on a private property is a covered wetland under the CWA. The bill is viewed as a “messaging bill,” and Representative Herrera Beutler will likely reintroduce it in the 116th Congress.

Orphan Hardrock Mine Cleanup Bills Introduced: On December 6, 2018, Senator Cory Gardner (R-CO) and Representative Scott Tipton (R-CO) introduced the Good Samaritan Remediation of Orphan Hardrock Mines Act of 2018, S. 3727 and H.R. 7226. The legislation would authorize EPA to establish a pilot program to promote the cleanup of orphan hardrock mines. Senator Gardner stated that “With the number of abandoned mines estimated to be as high as 500,000, Good Samaritans are needed to take necessary actions to clean up some of these sites.” Senator Gardner added that the assumption of liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the CWA has hindered cleanup of these sites. Under the bill, Good Samaritans could remediate the sites without the assumption of long-term liability.

Congressional Democrats Name Committee Leaders For New Congress: Democratic lawmakers have chosen most of their Committee leaders for the incoming 116th Congress. The House Democratic Steering and Policy Committee made its recommendations, although the full caucus must approve the slate of choices, and a few must wait until the House speakership contest is settled. The Senate roster is set. The two Committees that oversee the bulk of issues of relevance to our clients are the House Energy and Commerce Committee (E&C) and the Senate EPW Committee. Representative Frank Pallone, Jr. of New Jersey will move up from the E&C Ranking Member slot to Chair of the Committee, while Senator Tom Carper of Delaware retained his Ranking Member slot on EPW.

MISCELLANEOUS

OMB Releases Report On Regulatory Reform: OMB released its report detailing the regulatory reform results from FY 2018 (Regulatory Reform under Executive Order 13771: Final Accounting for Fiscal Year 2018). The results are, according to OMB: federal agencies accelerated the pace of regulatory reform in FY 2018; agencies eliminated $23 billion in overall regulatory costs; agencies issued 176 deregulatory actions and 14 significant regulatory actions, a 12 to 1 ratio; and 57 deregulatory actions were significant. Comparing significant deregulatory to significant regulatory actions yields a ratio of 4 to 1. In FY 2019, agencies anticipate saving a total of $18 billion in regulatory costs from final rules. This does not include “The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks,” which the proposed rule estimates will save between $120 and $340 billion in regulatory costs.

European Court Denies Appeal To Disclose Testing Information Related To Glyphosate Authorization: On November 21, 2018, in the Court of Justice of the EU, the Fourth Chamber of the General Court (General Court/Fourth Chamber) issued a judgment in the appeal case T-545/11 RENV that denied all three pleas on appeal and prevented applicants Stichting Greenpeace Nederland and Pesticide Action Network Europe (Applicants) from receiving certain documents containing confidential information relating to the first authorization of the placing of glyphosate on the market as an active substance, specifically the complete list of all tests submitted by the operators seeking the inclusion of glyphosate in Annex I to Directive 91/414. The judgment provides a detailed history of the case, beginning in 2010, when Applicants requested access to the documents in question. In this initial case, the Secretary General of the Commission agreed with the Federal Republic of Germany’s decision to refuse access to the documents (contested decision) on the basis that disclosure in Article 4(2) of Regulation No. 1049/2001 would undermine protection of the commercial interests of a natural or legal person. In upholding Germany’s decision, the Secretary General found that there was “no evidence of an overriding public interest in disclosure” within the meaning of Article 4(2) of Regulation No. 1049/2001, and also that the information “did not relate to emissions into the environment” within the meaning of Article 6(1) of Regulation No. 1367/2006 concerning public disclosure of information on the environmental effects of glyphosate. As such, “protection of the interests of the manufacturers of that substance had to prevail.” The Applicants brought an action for annulment of the contested decision to the Registry of the General Court. After one of the documents at issue (a draft assessment report issued by Germany prior to the initial inclusion of glyphosate in Annex I to Directive 91/414) was produced to the court (but still not released to the Applicants), the General Court ruled to annul the contested decision. The Commission appealed this annulment, stating that the General Court erred in its interpretation of the term “information [which] relates to emissions into the environment.” The Court of Justice was persuaded by this argument, set aside the initial judgment, and referred the case back to the General Court. The case was then assigned to the Fourth Chamber. The dispute was limited to the part of the document at issue that “contains information on the degree of purity of the active substance, the ‘identity’ and quantities of all the impurities present in the technical material, the analytical profile of the batches, and the exact composition of the product developed.” For more information, see our full blog.

U.S. Government Report Issues Blunt Warnings About Consequences Of Climate Change: On November 23, 2018, the U.S. Global Change Research Program (USGCRP) proclaimed stark warnings about the impact of climate change upon the U.S. Spanning over 1,600 detailed pages, the Fourth National Climate Assessment (NCA4) (available online) “is an authoritative assessment of the science of climate change,” according to the authors. Authored by scientists from 13 different federal agencies, the report is precise, methodical, and dire; among other things, the authors predict that if climate change impacts are left unchecked, the U.S. economy will shrink by at least ten percent. Virtually no aspect of current life and conditions in the U.S. will be untouched by the impacts of rising temperatures, the report concludes. The NCA4 is mandated by the Global Change Research Act of 1990 (Pub. L. No. 101-606, 104 Stat 3096–3104, November 16 1990, available online). The report warns that global warming “is transforming where and how we live and presents growing challenges to human health and quality of life, the economy, and the natural systems that support us.” It concludes that humans must act aggressively to adapt to current impacts and mitigate future catastrophes “to avoid substantial damages to the U.S. economy, environment, and human health and well-being over the coming decades.” The report assesses climate change’s impacts across a dozen broad areas.

NAFTA Replacement Signed: On November 30, 2018, President Donald J. Trump, Canadian Prime Minister Justin Trudeau, and outgoing Mexican President Enrique Peña Nieto signed the U.S.-Mexico-Canada (USMCA) trade agreement to replace the North American Free Trade Agreement (NAFTA). The accord must be approved by Congress. President Trump sent the text of the USMCA to lawmakers on Friday on the hope that the lame duck Congress would pass it before Democrats retake the House in January. Aboard Air Force One returning from the G20 summit, President Trump on December 1, 2018, also stated that he will withdraw the U.S. from NAFTA, a move intended to force Congress to pass the USMCA quickly. If he follows through with the withdrawal, lawmakers will have six months to pass the measure. If they fail to do so, both NAFTA and the USMCA will be void. The agreement faces a tough battle in the next Congress. It will have to survive the gauntlet of Democratic leaders and allied labor and environmental groups who agree that the deal needs substantial revision. House Democratic Leader Nancy Pelosi, who is expected to be the Speaker of the House when the new Congress convenes, criticized the USMCA for failing to set up a system to enforce adequately labor and environmental standards, a complaint echoed by labor unions and environmental groups. Environmental groups have been highly critical of the USMCA; the Sierra Club said in a statement that the accord “takes a significant step backwards” from environmental protections. AFL-CIO President Richard Trumka on November 30, 2018, called for a major rewrite of the deal.

OSHA Proposes To Revise Beryllium Standard For General Industry: On December 11, 2018, the Occupational Safety and Health Administration (OSHA) proposed to revise the beryllium standard for general industry (29 C.F.R. § 1910.1024). 83 Fed. Reg. 63746. On January 9, 2017, OSHA published a final rule revising the standard. 82 Fed. Reg. 2470. In that rule, OSHA concluded that employees exposed to beryllium and beryllium compounds at the preceding permissible exposure limits (PEL) were at significant risk of material impairment of health, specifically chronic beryllium disease (CBD) and lung cancer. OSHA thus lowered the 8-hour time-weighted average (TWA) PEL to 0.2 micrograms per cubic meter (µg/m3) to reduce this risk. In the final rule, OSHA issued separate standards for general industry, shipyards, and construction. In addition to the revised PEL for each of the three standards, OSHA also promulgated a new short-term exposure limit (STEL) of 2.0 µg/m3 over a 15-minute sampling period and an action level of 0.1 µg/m3 as an 8-hour TWA, along with ancillary provisions intended to provide additional protections to employees. These included requirements for exposure assessment, methods for controlling exposure, respiratory protection, personal protective clothing and equipment, housekeeping, medical surveillance, hazard communication, and recordkeeping. The December 11, 2018, proposal would amend the beryllium standard for general industry to clarify certain provisions and simplify or improve compliance. The compliance obligations affected by this rulemaking began on December 12, 2018. Other compliance obligations are not effective until 2019 or 2020. OSHA believes that the standard as modified by this proposal would provide equivalent protection to the current standard. Accordingly, OSHA will accept compliance with the proposed standard as compliance with the standard. The proposed rule would affect approximately 50,500 workers employed in general industry and is estimated to yield minor net cost savings to employers. The comment period on the proposal closes on February 11, 2019.

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